Navigating Data Integrity & Regulatory Compliance in GxP Laboratory Equipment

Live Air Date: Thu, Aug 17, 2017 9:12 AM EDT{LOCAL_TZ}

31 mins  

Event Overview

This webinar will help attendees understand the current issues surrounding data integrity and how essential compliance factors need to work together in the lab to ensure GxP environments meet today’s tough regulatory standards.  Learn what the FDA’s data integrity expectations are and what’s required to avoid issues and being caught unprepared in the face of inspections and mandatory requests for documentation.


Presenters


Margaret Blackburn
Global Lead for Compliance Services
Perkin Elmer

Margaret Blackburn is a Quality and Compliance veteran in the industry. CQA certified, she has been involved in quality auditing more than 15 years for both internal and external inspections. Her background is developing and implementing quality systems that are the right fit for a company, writing quality manuals, validating instrument and clinical methods, developing quality procedures and policies that are aligned with cGXP and cultivating a quality atmosphere not only intradepartmental but companywide. She has participated on working groups for CPT code approvals through the AMA, managed product lines of novel tumor markers and served as SME for beta testing and new site implementation of the product. Her experience in industry ranges from Quality Directorships and Chief Compliance Officer to Product Manager for international medical device, national reference laboratories, blood banking, biotech, CRO and BSL3 companies. She has recently joined the Perkin Elmer team as the Global Lead for Compliance Services.





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  • On-site Services
  • Laboratory Lifecycle Management
  • Preventative Maintenance and Repair
  • Laboratory Relocation
  • Qualification, Validation and Calibration
  • Asset management, Tracking and Monitoring
  • Analytics
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